Pharmaceutical advertising regulation and medical device advertising in Spain

Applicable to both medicines and medical devices:

• General Advertising Act 34/1998 of 11 November
• General Health Act 14/1986 of 25 April.
• Re-casted Act on guarantees and rational use of medicines and medical devices passed by Royal Decree Legislative 1/2015 of 24 July.

1.1 Medicines

• Royal Decree 1416/1994 of 25 June on advertising of medicines for human use
• Circular 6/95 issued by the Spanish Agency of Medicines and Medical Devices (“AEMPS”), further developing RD 1416/1994.
• Guidance dated June 2019 issued by the Ministry of Health on advertising to the general public of medicines for human use, further developing RD 1416/1994 

1.2 Medical Devices 

Additionally, it should be noted that the health competences in Spain are attributed to the Autonomous Communities. Therefore, advertising of medicines and medical devices will also be subject to obligations arising from the local regulation. 

Please find below the most relevant Spanish self regulatory codes governing the promotion and advertising of medicines and medical devices: 

2.1 Medicines

• Farmaindustria https://www.codigofarmaindustria.org/sites/sarfi/codigo/codigo.html
• Association for Health Self-Care (ANEFP) https://anefp.org/sites/default/files/2022-02/C%C3%B3digo-normas-deontologicas-anefp-menosreme_sep21.pdf and https://anefp.org/sites/default/files/2022-11/Codigo-normas-deontologicas-productos-autocuidado-anefp-2020.pdf
• Spanish Association of Generic Medicines (AESEG): https://www.aeseg.es/documentos/codigo-conducta.pdf 

2.2 Medical devices 

 Spanish Federation of Healthcare Technology Companies (FENIN). https://www.fenin.es/system/documents/document/document/1164/New_Version_Code_of_Ethics.pdf

3.1 Advertising to the general public

• OTC medicines: no licenses/approvals/fees required at national level. Nevertheless, the competent health administrations of the relevant autonomous communities may carry out controls. In this regard, the Community of Madrid requires the pharmaceutical laboratories with registered offices in the Community of Madrid to communicate any advertising activity for its medicinal products at the time of broadcasting the promotional material.
• Medical devices: prior authorisation.

3.2 Advertising to healthcare professionals 

• Medicines: prior communication.
• Medical devices: no licenses/approvals/fees required.

Yes, in particular advertising of prescription-only medicines to the general public is prohibited.  

5.1  Medicines 

Advertising of medicines to the general public is prohibited in the following cases:

• Prescription-only medicines.
•  Medicines reimbursed by the Spanish National Health System (“SNS”).
• Medicines containing narcotics or psychotropic substances.

When allowed, advertising of medicines to the general public shall not include any element which:

• Attributes to the medical consultation or surgical intervention, a superfluous character, especially by offering a diagnosis or advising a treatment by correspondence.
• Suggests that its effect is assured, that it has no side effects or that it is superior or equal to that of another treatment or other medicine.
• Suggests that the user's health may be improved by its use, or may be affected if it is not used; the latter prohibition shall not apply to certain vaccination campaigns.
•  Suggests or indicates that its use enhances sporting performance.
•  It is directed exclusively or mainly at children.
• refers to a recommendation made by scientists, health professionals or other persons who may, due to their notoriety, encourage the consumption of medicinal products.
• Equates the medicine with a food product, a cosmetic product or any other consumer product.
• Suggests that the safety or efficacy of the medicine is due to the fact that it is a natural substance.
• May, by means of a detailed description or representation of the anamnesis, lead to a false self-diagnosis.
• Refers in an abusive, alarming or misleading manner to claims of cure.
• Uses in an abusive, alarming or misleading manner, visual representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts of the human body.
• Mentions that the medicinal product has received health or other authorisation.

It is also prohibited to include expressions that provide assurance of a cure, or testimonies about the virtues of the product, or from professionals or persons whose notoriety may induce consumption as well as  use as an advertising claim the fact of having obtained a health/sanitary authorisation in any country or any other required authorisation, sanitary registration number or certification. 

In addition, the following therapeutic indications are prohibited from being mentioned in advertising to the public:

• Tuberculosis.
• STIs.
• Other serious infectious diseases.
• Cancer and other tumour diseases.
• Chronic insomnia
• Diabetes and other metabolic diseases. 

5.2 Medical devices 

Advertising of medical devices to the general public is prohibited in the following events:

• Medical devices reimbursed by the SNS.
• Medical devices intended for use or application only by HCPs.

When allowed, any reference to a health authority or to recommendations made by scientists, health professionals or other persons who may, because of their reputation, encourage their use is prohibited. This prohibition does not apply to advertising promoted by public administrations.  

Under Spanish regulations on medicines and medical devices, in order to guarantee the independence of the decisions relating to the prescription, dispensing, and administration of medicines and medical devices from commercial interests, is prohibited:

To:

• offer, directly or indirectly, any type of incentive, bonus, discounts or gifts (with the exception of those which are of insignificant value) to HCPs, their relatives and cohabitants 

7.1  Medicines 

Any advertisements directed to HCPs shall provide the technical and scientific information necessary for the HCPs to be able to judge for themselves the therapeutic value of the medicine, and shall at least, include:

• The essential product information according to the data contained in the data sheet, including, at least: name of the medicine; qualitative and quantitative composition; complete clinical data; incompatibilities; instructions for use/handling, and name and address of the marketing authorisation holder.
• Prescription and dispensation regime.
• The different presentations of the medicine, if any, and the dosage and/or pharmaceutical form.
• The retail price, reimbursement conditions, and, where appropriate, an estimate of the cost of treatment.
• The date on which the documentation was drawn up or last revised.

7.2 Medical devices 

The advertisement shall be essentially scientific, and the information shall be provided by persons adequately trained and possessing sufficient knowledge to give accurate and comprehensive guidance on the devices being promoted. The advertisement shall include:

• All technical data necessary for an objective assessment to be made of the usefulness of the medical device.
• A mention to the conformity of the medical device with the legislation in force.
• Information on any contraindications and possible side effects that could result from the use of the medical device.      

8.1 Medicines 

Advertising of medicines to the general public shall:  

be carried out in such a way that the advertising nature of the message is obvious, and it is clearly specified that the product to be advertised is a medicine and shall include, at least, the following information:

• Name of the medicine, as well as the common name when the medicine contains a single active ingredient.
• Essential information for the correct use of the medicine,
• An express and clearly visible warning to read carefully the instructions on the leaflet or on the packaging.
• A recommendation to consult the pharmacist on its correct use.
• Identifying data and recommendations as determined by the Ministry of Health to avoid abuse and to prevent the risks associated with the normal use of the medicine.
• The essential information required for the proper use of the medicine. 

8.2 Medical devices 

The advertisement shall be essentially scientific, and the information shall be provided by persons adequately trained and possessing sufficient knowledge to give accurate and comprehensive guidance on the devices being promoted. The advertisement shall include:

• All technical data necessary for an objective assessment to be made of the usefulness of the medical device.
• A mention to the conformity of the medical device with the legislation in force.
• Information on any contraindications and possible side effects that could result from the use of the medical device.

Any scientific data indicated in advertisements must be in accordance with the technical and scientific information authorised by the AEMPS and must be rigorous, well-founded and objective, and not misleading. 

Moreover, all information whose typographical features shall normally be legible, shall be accurate, verifiable and sufficiently complete and up to date to enable the recipient to judge for himself the therapeutic value of the medicinal product.

Likewise, quotations, tables and other illustrations taken from medical journals or scientific works shall be faithfully reproduced and their source accurately stated. 

In general terms, comparative advertising is prohibited when not based on essential and similar characteristics of the products or services, which cannot be objectively proven, or when the products or services subject to comparison are not similar or one of them is unknown or has a limited participation in the market. 

In particular with regards to the advertising of medicines and medical devices advertising to the general public shall not include any element which suggests that it is greater than or equal to that of another treatment or medicine. 

Advertising of medicines and medical devices on the internet/social media is subject to all the controls, prohibition and requirements detailed in the previous sections. 

The competent authorities for monitoring compliance are both the AEMPS and the local health authorities. 

However, it is quite common that advertising disputes are brought to the relevant self-regulation bodies (Farmaindustria, Autocontrol, Fenin, etc.). 

Failure to comply with the applicable regulation to the advertising of medicines and medical devices may result in fines from EUR 30,001 to EUR 90,000 in case of infringements regarding medical devices advertisement; or from EUR 90,001 to EUR 1,000,000 (this amount might exceed by up to five times the value of the goods or services which are the object of the infringement) in case of infringements regarding medicines advertisement. 

Likewise, the failure to comply with advertising rules may lead to civil and/or criminal liability. 

As a result of the approval of the new Royal Decree 192/2023 of 21 March, which regulates medical devices, new specific regulation on the advertising of medical devices is currently being discussed. In the meantime, the regulation foreseen in this matter in Royal Decree 1591/2009 of 16 October on medical devices remains in force. There is no date foreseen for the approval of this new regulation.

In the context of the Spanish market, a bill of royal decree on promotion of medicines and medical devices is still being processed within the Ministry of Health. One of its goals is to adapt the regulations to the current demands, in which there is a clear predominance of digital and audiovisual media.